Subjects that are indicated for standard colonoscopy due to suspected or known Ulcerative colitis disease

Detailed Description:

Ulcerative colitis (UC) is a disorder of unknown origin that may be characterized by acute and chronic inflammation of the colon. The extent of the colonic mucosal inflammation varies among individuals, but the disease almost always involves the rectum. Ulcerative colitis has required evaluation by colonoscopy to determine the extent and severity of the disease. The PillCam platform offers an alternative approach for endoscopic visualization of the colon using capsule endoscopy, a swallowable device which contains imagers, light sources, a power source and a RF transmitter. Advantages of the PillCam platform include the elimination of the need for conscious sedation, the minimally invasive, painless nature of the exam, and the ability to pursue normal daily activities immediately following the procedure . Furthermore, compared to standard colonoscopy, the PillCam platform may be more readily accepted by the subjects, thereby improving subjects' willingness to undergo a diagnostic evaluation of the colon.

The PillCam® SB capsule (formerly M2A® Capsule) that was FDA-approved in August 2001 for small bowel evaluation has been ingested to date by more than 700,000 people worldwide and is well accepted by patients and physicians as well as the professional societies. However, adequate visualization of the colon cannot be achieved with the standard PillCam™ SB capsule because of the anatomical and physiological properties of the colon which are significantly different than the small bowel. Moreover, other issues that limit the evaluation of the colonic mucosa by the standard PillCam™ SB procedure include an unsatisfactory level of colon cleanliness and slow progression of the PillCam™ SB capsule through the colon during the desired examination time. Therefore, the development and introduction of a specially designed, customized colon capsule combined with a dedicated capsule colonoscopy procedure protocol will allow for more efficient evaluation of the colonic mucosa. Further details of the PillCam® Colon Capsule Endoscope (PCCE) can be found in the device description section.

In previous studies, the PillCam colon platform has been shown to be safe and to be able to demonstrate colon polyps and cancers. This study is an extension to a trial evaluating the use of PCCE in ulcerative colitis that has already been completed in Hong Kong (n=40). This study is designed to assess the ability of the capsule to accurately detect inflammatory lesions and thus classifying the extent and severity of disease in subjects with ulcerative colitis in comparison to traditional colonoscopy.

Eligibility

Ages Eligible for Study:

18 Years to 70 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Probability Sample

Study Population

Subjects that are indicated for standard colonoscopy due to suspected or known Ulcerative colitis disease

The study population will consist of subjects who fulfill all the inclusion criteria and none of the exclusion criteria.

Criteria

Inclusion Criteria:

Subjects 18-70

Suspected or known ulcerative colitis patients

Exclusion Criteria:

Subject has dysphagia

Subject has congestive heart failure

Subject who can not tolerate bowel preparation

Poor bowel preparation

Subject has renal insufficiency

Subject is known or is suspected to suffer from intestinal obstruction.

Subject has a cardiac pacemaker or other implanted electro-medical devices.

Subject is pregnant

Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.

Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.

Subject has any condition, which precludes compliance with study and/or device instructions.

Subject suffers from life threatening conditions

Subject is currently participating in another clinical study

Subject has constipation (less than 3 bowel movements/week)

Subject has known slow gastric emptying time

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604422